AccessGUDID - DEVICE: Pointe Ethyl Alcohol Reagent Set (00811727017390)

GUDID

Device Identifier (DI) Information

Brand Name: Pointe Ethyl Alcohol Reagent Set
Version or Model: 60-EA0440-100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 60-EA0440-100
Company Name: POINTE SCIENTIFIC, INC.

Primary DI Number: 00811727017390
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 045623154 *Terms of Use

Device Description: Pointe Ethyl Alcohol Reagent Set 1 x 100 mL R1, 1 x 37.5 mL R2 The Pointe Ethyl Alcohol Reagent Set is intended for the quantitative determination of ethyl alcohol in human urine, serum or plasma. The assay is designed for prescription use with a number of automated clinical chemistry analyzers.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
55607	Ethanol (ETOH) IVD, kit, enzyme spectrophotometry	A collection of reagents and other associated materials intended to be used for the quantitative measurement of ethyl alcohol (ETOH) in a clinical specimen, using an enzyme spectrophotometry method. It is typically used to assess for alcohol intoxication and in the management of alcoholism.	Obsolete	false

FDA Product Code

[?]

Product Code	Product Code Name
DIC	Alcohol Dehydrogenase, Specific Reagent For Ethanol Enzyme Method

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K032461	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 2 and 8 Degrees Celsius

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b30355aa-76ae-4b5a-a4ef-49eeea700b09
Public Version Date: October 05, 2020
Public Version Number: 1
DI Record Publish Date: September 25, 2020